Five minutes at CPhI worldwide with …
CO/PH: You recently opened facilities in China, Brazil, and in other countries. Is JRS Pharma expanding a lot?
Yvonne M. Johnson: We just had the inaugural ribbon-cutting ceremony in China for our sixth manufacturing plant of microcrystalline cellulose in September. It’s in Changzhou.
The highly developed Yangtze Delta region encompasses the major cities of of East China which covers approx. 40 % of China’s fast-growing pharmaceutical industry.
The industry trend is to consolidate and have a geographical footprint all around the globe. We see a lot of growth in India and China right now; as a supplier, we can’t ignore that. The reasons to have several manufacturing sites in close physical proximity to our customers arose over the past few years in the aftermath of unexpected circumstances ranging from natural calamities like hurricanes and tsunamis to the financial collapse of South Korea’s main shipping and transport line.
In the face of such challenges, our customers might suddenly find themselves in jeopardy of costly production delays. By establishing new production sites closer to the customer’s location, we can ensure a more reliable supply of the materials they need to manufacture their pharmaceuticals in a timely manner.
CO/PH: What about biologics?
YMJ: The dominance of small-molecule drugs is coming to an end. In the future more treatments will be biologic – complex drugs. In order to meet this growing demand of the health science industry, JRS has created JRS Pharma with the development of a broader portfolio of solutions through CELONIC as CDMO and PROJECT PHARMACEUTICS as CRO.
Their services included production processes, as well as the GMP and non-GMP manufacturing of biopharmaceutical drug substances. To complement the services, our CDMO is also proposing 2 innovative cell expression systems (GEX® and CHOvolution™) for simple or more complex target.
ProJect Pharmaceutics is a leading CRO with key expertise in formulation science and freeze drying technology. They resourcefully design tailored pharmaceutical formulations that render towards more stable, safer and convenient biologicals and shape cost-effective manufacturing processes, tailor-made for the formulation. This is the basis for drug products to run smoothly in large scale GMP manufacturing.
Actually, this is not brand new for us – we’ve been doing this for a few years – but our customers are probably not so aware of these services and platforms.
CO/PH: What challenges do biologics pose for excipients?
YMJ: Biologic drugs are highly complex molecules produced by living cells through and extensive development processes. Increasing demand for biologics – both biosimilar and new biological entities – are shaping up new opportunities for advance functional excipients, in process development as well as in targeted drug delivery. We believe that excipients that can improve process yield and strengthen process robustness will carve out an equally important category as the excipients addressing bioavailability challenges of new biologics.
CO/PH: What’s your take on continuous manufacturing (CM)?
YMJ: CM is a very hot topic in the industry. I just came out of a discussion with a leading manufacturer of tableting and granulation machines which confirmed my impression that it is a growing trend in the industry. The question is: “What does the new technology require from an excipient?” In practice, you need to have great blending opportunities that prevent particle segregation in order to absolutely guarantee that the amount of API is consistent among all tablets. Here in Germany, we have the Autobahn and many people are pleasantly impressed by these high-speed roads. But if you want to drive on a high-speed road, you need a high-performance car! By that analogy, with continuous manufacturing, your high-performance car would be our high-functionality excipients.
We are planning to open up another plant for HFE in India in the next future. It is unbelievable, the fast industry growth and the level of enthusiasm you see there to adopt better and more efficient technologies.
CO/PH: Are you active in India?
YMJ: We established a JRS sales company in Mumbai, and have two joint ventures there with local production for four of our product groups. If you follow market analysis — or word-of-mouth from clients — India has the largest industry growth and is predicted to remain strong in the future. They are now getting into biologics, nutrition, and dietary and herbal supplements. We also see that Bangladesh is growing also due to their peculiar patent laws. As a LDC country (least developed countries) and member of the WTO Bangladesh will continue to enjoy the maximum flexibility regarding patented products till December 2032.The Bangladeshi consider themselves a “small India,” not unlike the way Canada compares to the USA.
CO/PH: What about Middle East and Russia?
YMJ: The Middle East and Russia are very interesting markets. In Russia, the official government policy of import substitution in the field of finished pharmaceuticals is forcing global manufacturers to build local production sites there. In addition, the Russian state supports the pharmaceutical industry in terms of infrastructure and tax incentives. They created several so-called pharmaceutical clusters where conditions are especially favourable, such as the Moscow, St Petersburg, Kaluga, Yaroslavl and other regions. All of that positively affects the growth of demands for raw materials for the pharmaceutical industry.
CO/PH: What future direction is JRS taking? Are you broadening your portfolio?
YMJ: The main volume of our business still comes from the MCC. We consider ourselves the market leader in microcrystalline cellulose, thanks to our six manufacturing facilities all around the globe. Microcrystalline cellulose has long been the preferred binder/filler for tablet formulation. But what does the industry want these days? A one-stop shop. So we expanded our portfolio by manufacturing lubricants, superdisintegrants, and so forth. The latest integration involved adding povidone lines, thanks to a joint venture with SSP, a dedicated CGMP manufacturer in Chongqing, China, in January 2016 Povidones are used in technologies such as hot-melt extrusion, a technology that we will see more and more in the future. to accelerate drug release. We aim to become a market leader in povidones as well.